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Protein Synthesis Inhibitor

DOXIL/CAELYX in combination with VELCADE (bortezomib) for Multiple Myeloma

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 9 years and 5 months (from date of first participant randomization [20 december 2004] to cut-off date for final survival analysis (16 may 2014)

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

The purpose of this study is to evaluate time to progression, overall survival, response rate and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE vs. VELCADE monotherapy.

Eligible Conditions

Multiple Myeloma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year and 4 months (from date of first participant randomization [20 december 2004] up to interim analysis cut-off date [28 april 2006])

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year and 4 months (from date of first participant randomization [20 december 2004] up to interim analysis cut-off date [28 april 2006])

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year and 4 months (from date of first participant randomization [20 december 2004] up to interim analysis cut-off date [28 april 2006]) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to Progression (TTP)

Secondary study objectives

Number of Participants With Serious Adverse Events (SAEs)

Overall Survival

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DOXIL/CAELYX in combination with VELCADE (bortezomib)Experimental Treatment2 Interventions

Bortezomib (VELCADE) 1.3 mg/m\^2 by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m2 by i.v. infusion will be given on Day 4 of every 21-day cycle after the administration of bortezomib (VELCADE) for up to 8 cycles.

Group II: VELCADE (bortezomib) monotherapyActive Control1 Intervention

Bortezomib (VELCADE) 1.3 milligram per meter square (mg/m\^2) by rapid (bolus) i.v. administration given on Days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib D-mannitol

FDA approved

Doxorubicin

FDA approved

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